Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials

Area of Science:

• Dermatology and Pigmentation Disorders
• Clinical Trial Methodology
• Health Outcomes Research

Background:

• Postinflammatory hyperpigmentation (PIH) significantly impacts quality of life, especially in individuals with skin of color.
• Current clinical trials for PIH report diverse outcomes, hindering result synthesis and treatment comparisons.
• Standardized outcome measures are needed to improve the reliability and comparability of PIH research.

Purpose of the Study:

• To describe the design of a consensus process for developing a core outcome set for postinflammatory hyperpigmentation (PIH) clinical trials.
• To establish a standardized set of outcomes for consistent assessment in all future PIH studies.
• To facilitate aggregation and comparison of research findings across different treatment modalities.

Main Methods:

• Systematic review and stakeholder interviews to generate a long list of candidate outcomes.
• Steering committee review and refinement of the candidate outcomes.
• Two rounds of Delphi surveys with patients and physicians, followed by a consensus meeting to finalize the core outcome set.

Main Results:

• The protocol outlines a structured consensus process involving multiple stakeholder groups.
• The process aims to identify and validate a definitive core outcome set for PIH trials.
• Successful development of a core outcome set is anticipated.

Conclusions:

• A standardized core outcome set for PIH will enhance consistency in clinical trial reporting.
• Improved reporting will facilitate meta-analysis and direct comparison of treatment efficacy.
• This initiative is expected to advance the scientific understanding and management of postinflammatory hyperpigmentation.